Datubo Stewart

Responsibilities:

• · Leading Design Transfer and Manufacturing teams, mentoring and coaching junior engineers and technicians, streamlining processes, ensuring quality, and maintaining compliance with industry standards.
• · Overseeing change management, process development, risk management, design for manufacturing, validation, KOL interaction, product management, and supplier management.
• · Collaborating with cross-functional teams on all design control deliverables for new products from concept to 510(k) clearance and full commercial launch
• · Collaborate with the supply chain team to strategically plan and select vendors, ensuring alignment with production goals, cost efficiency, and quality standards.
• · Collaborate with cross-functional teams to determine annual operating (OPEX) and capital (CAPEX) expenditures.
• · Participate in the preparation and presentation of annual budget proposals to senior management.

Accomplishments:

• · Successfully managed the cost reduction initiative for all legacy bone screws by analyzing historical data and conducting retrospective process qualifications to reduce in process inspections of parts resulting in 15% cost savings and 20% reduction in production time
• · Implemented a streamlined DFM (Design for Manufacturability) process, reducing time-to-market by 30%
• · Led the cross-functional team for the PILLAR SA Ti (Spine Implant) project, achieving 510(k) clearance and meeting all project milestones ahead of schedule.
• · Coordinated the launch of in-house sterile packaging project , managing all aspects of project planning, execution, and monitoring.
• · Created and managed budgets for acquiring new machinery. Tracked and reported the performance and results of newly integrated equipment, ensuring alignment with production goals and budget constraints
• · Led a cross functional supplier development team in coordinating kaizen events and value stream mapping at multiple supplier locations to reduce waste , increase first pass yield to 95% and reduce lead times by 35%

• · Developed and implemented company-wide cost model using Microsoft Excel for additive manufacturing process which helped with baseline negotiations with contract manufacturer.
• · Led cross-functional team for C-Mini Ti and Forza Ti (Spine fusion Implants) project, achieving 510(k) clearance and meeting all project milestones ahead of schedule.
• · Managed supplier development initiatives by performing Kaizen events at various supplier facilities to map out processes, reduce waste, minimize scrap, and increase yield, targeting 95% yield rate.
• · Managed vendor 15 NDA’s, commercial items, contracts, and terms-conditions.
• · Promoted to Senior Level after 2 years for leading manufacturing initiatives in production and product development.

• Procured and implemented GoCanvas software, streamlining daily operations for quality inspectors, expediting part inspections, and enhancing data collection for continuous process improvement with goal to reduce scrap rate by 20%
• Led Corrective Action Preventative Action (CAPA) program with root cause analysis, investigating failures, re-work plan, deviations and non-conformances.

• Led product development from concept to full commercial launch of REDAPT◊ 3D printed Titanium hip replacement system.
• Validated equipment and processes through comprehensive IQ/OQ/PQ protocols, ensuring adherence to standards and addressing deviations.
• Conducted statistical analysis on process capability data to ensure consistent and reliable manufacturing operations.
• Developed and managed risk assessments, control plans, and quality documentation, supporting internal and external audits including FDA and BSI.